You MUST have been a Pharmacovigilance Officer at a Pharmaceutical Company to apply.
A leading global multinational pharmaceutical company has an opportunity for an experienced Pharmacovigilance Officer / Drug Safety Officer to manage and maintain the Pharmacovigilance (PhV) function in South Africa to ensure regulatory compliance.
The oposition is part of the Regulatory Affairs team.
Regulatory Affairs Pharmacist with strong Pharmacovigilance experience are eligible for selection too.
The position is 'work from home' for now. Once Covid protocols allow, you may need to work from the office about two morings a week, and the rest of the time from home.
Duties & Responsibilities
• Establish and maintain a compliant Pharmacovigilance (PhV) system in South Africa
• Manages Company commercial partners from a PhV point of view
• Ensures compliance with applicable South African PhV regulations, as well as global and local PhV SOPs
• Keeps informed and updated on changes to local regulations and updates management (both local and regional) about it
• Serves as local representative for Company PhV for the SAHPRA; key contact point for PhV inspections and audits conducted in South Africa
• Ensures data privacy and confidentiality is maintained as required locally
• Ensures appropriate after hours provisions are in place and that a trained back-up is in place to ensure compliance during any absence
• Budget planning and control
• Makes sure there is appropriate recording and documentation of all procedures and other PhV documents subject to audit
• Maintains a local business contingency plan for PhV activities
• Participates in regional and global projects and working groups organised by Global PhV or regional PhV management
• Initiates and manages process improvement and promotes local PhV operational excellence in order to increase efficiency and maintain compliance
• Maintains local collection system for AEs and special situation reports (hereinafter individual safety reports)
• Ensures local AEs and special situation reports are received by PhV unit in timely manner and forwarded to the relevant data processing unit, as per Global PhV SOPs
• Maintains an interface with all local functions with the potential to receive individual safety reports, to ensure on time collection of all local individual safety reports by the PhV unit. This includes, but is not limited to Regulatory Affairs, Quality Assurance, Medical Information, PSPs, Sales representatives & Legal.
• Has oversight of local clinical study protocols and safety management plans to make sure safety reporting workflow is adequate and in line with company procedures
• Ensures case reconciliation with all internal and external partners, as appropriate
• Collaborates with company Periodic reports and risk management centre (TPC) on the process related to compiling and submission of periodic reports to the SAHPRA
• Coordinate appropriate provision of safety related information to safety queries received from healthcare professionals, patients and/or the SAHPRA on Company products marketed in South Africa, this in conjunction with Global PhV, as appropriate
• Ensures prompt notification of any local safety issues that arise, to the PhV regional manager and Global PhV
• Notifies the regional PhV manager of any local recalls
• Ensures quality control process for all outputs, and corrective and preventative actions for identified gaps
• Responsible for execution of CAPAs following internal compliance monitoring, audits and inspections, as well as in the event of deviations from SOPs & WIs, agreements and regulatory requirements
• Reviews all relevant local PhV SOPs, policies and working instructions and makes sure they are consistent with Global PhV SOPs and local regulatory requirements
• Ensures all required PhV Agreements are in place with local license partners and 3rd party service providers, incl. market research vendors, contract research organisations (CROs), patient support program service providers, call centres, commercial partners, etc.
• Ensures periodic reconciliation with business development and legal to make sure no agreements are missed
• Manages SAHPRA PhV inspections and audits by 3rd parties, in collaboration with Global compliance team
• Notifies Global compliance and regional managers of authority inspections
• Performs PhV audits of local 3rd parties and service providers
• Ensures PhV training is delivered to all Company South Africa personnel, as mandated by the relevant Global PhV SOP
• Ensures appropriate PhV training is delivered to third party companies, service providers, CROs and any other organisations contracted to Company that could receive individual safety reports
Internal (including, but not limited to):
• Quality Assurance
• Medical Affairs
• Sales and Marketing
• Business Development & Portfolio
• Regulatory Affairs
• Global Patient Safety
• Global Compliance Team
• Any other Company business units and functional teams as necessary
External (including, but not limited to):
• Health care professionals and patients/consumers
• Commercial partners
• Third party companies
• Service providers
• Regulatory Authority (SAHPRA)
• Pharmaceutical industry associations
Desired Experience & Qualification
EDUCATION & EXPERIENCE
• Relevant degree/diploma in the Health Sciences sector (This is a requirement) eg. B.Sc, Nursing etc.
• At least 2 years’ experience as a Pharmacovigilance Officer at a pharmaceutical company (This is a requirement)
• Pharmacovigilance experience within a multi-national company (preferred, not required)
• Strong communication skills in both verbal and written English
• lntegrity and a demonstrable sense of responsibility
Excellent references are a requirement.
Package & Remuneration
SALARY: Negotiable around R25k to R35k ctc per month for Half-Day position, includes medical aid and provident fund contributions.
There is an additional annual bonus incentive on top of this.
Salary negotiable based on experience and qualifications.
To apply please forward your confidential cv to EMAIL
Please quote reference “P37 PV”
Shortlisted candidates will be contacted within 3 working days.
Salary ranges and job descriptions are for advertising purposes only and are subject to change.
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